Clene Inc. (NASDAQ: CLNN) has announced significant advancements in its regulatory strategy for CNM-Au8, following a productive Type C meeting with the FDA. The meeting provided valuable feedback on the company’s statistical analysis plan (SAP) for evaluating neurofilament light (NfL) biomarker data from its Expanded Access Protocol for amyotrophic lateral sclerosis (ALS). Clene has since resubmitted a revised SAP and anticipates FDA acceptance this summer, with NfL analyses expected in early Q4 2025. These analyses are crucial for supporting a potential New Drug Application (NDA) submission under the accelerated approval pathway.
In addition to the progress in ALS, Clene has confirmed two further FDA meetings scheduled for Q3 2025. The first meeting will assess long-term ALS survival data, which could be pivotal for accelerated approval consideration. The second is an End-of-Phase 2 Type B meeting, aimed at reviewing Phase 2 multiple sclerosis (MS) trial results and discussing the design of a Phase 3 study focused on cognitive improvement. These developments underscore Clene’s commitment to addressing unmet needs in neurodegenerative diseases through innovative therapies like CNM-Au8.
CNM-Au8 is an investigational first-in-class therapy designed to enhance central nervous system cells’ survival and function by targeting mitochondrial health and reducing oxidative stress. Its potential to treat neurodegenerative diseases such as ALS, Parkinson’s disease, and MS represents a significant advancement in the field. The upcoming FDA meetings and the anticipated regulatory milestones highlight the importance of Clene’s work and its potential impact on patients suffering from these debilitating conditions.
For more information on Clene’s regulatory progress and the potential of CNM-Au8, visit https://ibn.fm/iLzgr.
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